This Laboratory Investigation training will provide guidance on procedures investigating unexpected results for Non-Clinical and Clinical Trials and will discuss several suggested procedures, avoiding unnecessary re-analysis.
Why Should You Attend:
Unexpected results in acceptable assays usually reflexively trigger calls for re-analysis by clinical managers or non clinical study directors. Before re-analysis is initiated compromising the sample, investigators must rule out pre-analytical errors, mislabeling, misdosing, delayed or accelerated sampling, subject variables (concurrent meds, fasting compromised, etc). This session will discuss several suggested procedures, hopefully avoiding unnecessary re-analysis. If re-analysis is still indicated at the end of the investigation, this session will suggest procedures.
Areas Covered in the seminar:
- FDA restriction and guidance covering sample re-analysis.
- Establishment of complaint handling program.
- What constitutes valid re-analysis.
- CRM/CRA/Medical Officer Requests for re-analysis.
- Pre-analytical errors and investigations.
- Analytical errors and investigations.
- Post analytical errors and investigations.
Who will benefit:
This webinar will provide valuable assistance to all regulated companies, since sample re-analysis issues will arise across the Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:
- Laboratorians
- Regulatory management
- QA management
- Clinical Research Managers and Associates
- Sales personnel
- Consultants
- Quality system auditors
